Medications & Supplements/Prescription Drugs

Sodium Bicarbonate, Midazolam, and ELCYS Injections Recalled for Silicone

Agency Publication Date: November 22, 2023

Summary

Exela Pharma Sciences LLC is recalling 416,845 units of three different injectable medications: 8.4% Sodium Bicarbonate Injection, Midazolam in 0.8% Sodium Chloride Injection, and ELCYS (cysteine hydrochloride injection). These products are being recalled because they may contain particulate matter consisting of silicone. These medications are sterile solutions used for intravenous administration in hospital and clinical settings.

Risk

Injecting medication that contains silicone particles can cause inflammation at the injection site or lead to serious complications such as blood clots, damage to organs, or life-threatening blockages in the blood vessels. No injuries or adverse events have been reported to date regarding this recall.

What You Should Do

This recall affects 8.4% Sodium Bicarbonate Injection (50 mL vials), Midazolam in 0.8% Sodium Chloride Injection (100 mL vials), and ELCYS (cysteine hydrochloride injection, 10 mL vials) distributed by Exela Pharma Sciences.
Identify affected Sodium Bicarbonate vials by NDC codes 51754-5001-1 or 72572-740-01. Because multiple batches are involved, see the Affected Products section below for the full list of affected lot numbers and expiration dates.
Identify affected Midazolam vials by NDC 51754-2131-1 and lot number 10001088 with an expiration date of 07/31/2024.
Identify affected ELCYS vials by NDC 51754-1007-1 and lot number 10000798 with an expiration date of 03/31/2025.
Stop using the recalled injectable products immediately and quarantine any remaining stock to prevent further clinical use.
Contact Exela Pharma Sciences LLC or your pharmaceutical distributor to arrange for the return of the affected medication.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: 8.4% Sodium Bicarbonate Injection, USP (50 mEq/50 mL)

Variants: 50 mEq/50 mL, 1 mEq/mL, Single Dose Vial

Lot Numbers:

P0001429 (Exp 11/30/2023)

P0001900 (Exp 08/31/2024)

P0001902 (Exp 08/31/2024)

P0001903 (Exp 09/30/2024)

P0001909 (Exp 09/30/2024)

P0001945 (Exp 09/30/2024)

P0002002 (Exp 11/30/2024)

P0002052 (Exp 12/31/2024)

P0001912 (Exp 08/31/2024)

NDC:

51754-5001-1

51754-5001-5

51754-5001-4

72572-740-01

72572-740-20

Includes product also labeled for Civica, Inc. (Lehi, UT).

Product: Midazolam in 0.8% Sodium Chloride Injection (100 mg/100 mL)

Variants: 100 mg/100 mL, 1 mg/mL, 100 mL Single-Dose Vial

Lot Numbers:

10001088 (Exp 07/31/2024)

NDC:

51754-2131-1

51754-2131-4

Product: ELCYS (cysteine hydrochloride injection), USP (500 mg/10 mL)

Variants: 500 mg/10 mL, 50 mg/mL, 10 mL Single Dose Sterile Vial

Lot Numbers:

10000798 (Exp 03/31/2025)

NDC:

51754-1007-1

51754-1007-3

Product Images

Image 1: “Exela brand 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL”

Image 2: “Civica brand 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL”

Image 3: “Exela brand Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL”

Image 4: “Exela brand ELCYS (cysteine hydrochloride Injection), USP 500 mg/10 mL”

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93265

Status: Active

Manufacturer: Exela Pharma Sciences LLC

Sold By: Hospitals; Clinics; Pharmaceutical distributors

Manufactured In: United States

Units Affected: 3 products (355,220 vials; 23,425 vials; 38,200 vials)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects 8.4% Sodium Bicarbonate Injection (50 mL vials), Midazolam in 0.8% Sodium Chloride Injection (100 mL vials), and ELCYS (cysteine hydrochloride injection, 10 mL vials) distributed by Exela Pharma Sciences.

Identify affected Sodium Bicarbonate vials by NDC codes 51754-5001-1 or 72572-740-01. Because multiple batches are involved, see the Affected Products section below for the full list of affected lot numbers and expiration dates.

Identify affected Midazolam vials by NDC 51754-2131-1 and lot number 10001088 with an expiration date of 07/31/2024.

Identify affected ELCYS vials by NDC 51754-1007-1 and lot number 10000798 with an expiration date of 03/31/2025.

Stop using the recalled injectable products immediately and quarantine any remaining stock to prevent further clinical use.

Contact Exela Pharma Sciences LLC or your pharmaceutical distributor to arrange for the return of the affected medication.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Affected Products

Product: 8.4% Sodium Bicarbonate Injection, USP (50 mEq/50 mL)

Variants: 50 mEq/50 mL, 1 mEq/mL, Single Dose Vial

Lot Numbers:

P0001429 (Exp 11/30/2023)

P0001900 (Exp 08/31/2024)

P0001902 (Exp 08/31/2024)

P0001903 (Exp 09/30/2024)

P0001909 (Exp 09/30/2024)

P0001945 (Exp 09/30/2024)

P0002002 (Exp 11/30/2024)

P0002052 (Exp 12/31/2024)

P0001912 (Exp 08/31/2024)

NDC:

51754-5001-1

51754-5001-5

51754-5001-4

72572-740-01

72572-740-20

Includes product also labeled for Civica, Inc. (Lehi, UT).

Product: Midazolam in 0.8% Sodium Chloride Injection (100 mg/100 mL)

Variants: 100 mg/100 mL, 1 mg/mL, 100 mL Single-Dose Vial

Lot Numbers:

10001088 (Exp 07/31/2024)

NDC:

51754-2131-1

51754-2131-4

Product: ELCYS (cysteine hydrochloride injection), USP (500 mg/10 mL)

Variants: 500 mg/10 mL, 50 mg/mL, 10 mL Single Dose Sterile Vial

Lot Numbers:

10000798 (Exp 03/31/2025)

NDC:

51754-1007-1

51754-1007-3